Quality Control Analyst II

BioPharma Consulting JAD Group; Norton (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a QC Operations Analyst II Contractor to support analytical testing, data trending, and lab operations from development through commercialization. You will help with method transfers, validations, and regulatory readiness while ensuring GMP/GLP compliance.

The role requires 4–8 years in pharmaceutical/biotech QC, proficiency with LabWare LIMS, and strong technical writing. Weekend shift coverage is required at Norton, MA with initial training.

Qualifications

• B.S. in chemistry, biology, biochemistry or related field; 4-8 years pharma/biotech GMP QC experience.
• Experience in method transfer/implementation and method lifecycle management.
• Strong writing, data analysis, problem-solving, and organizational skills.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint.

Responsibilities

• Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for materials and products.
• Support weekend lab operations and maintain training records.
• Assist in lab equipment and inventory maintenance, including reagent and sample prep.
• Review data timely and qualify as a data reviewer; perform operational assignments.
• Contribute to updating SOPs, work instructions, and test methods.
• Support regulatory submissions, inspection readiness, and audits.

Skills

Analytical testing

Data analysis

Technical writing

Problem-solving

Organizational skills

Education

B.S. in chemistry or related field

Tools

LabWare LIMS

Excel

Word

PowerPoint

Job description

The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.

Key Responsibilities

• Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs.
• Support weekend lab operations and maintain training records.
• Assist in lab equipment and inventory maintenance, including reagent and sample prep.
• Review data timely and qualify as a data reviewer Perform operational assignments (raw material processes, environmental monitoring, in-process testing).
• Contribute to updating controlled documents (SOPs, work instructions, test methods).
• Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH) Participate in continuous improvement initiatives and cross-functional collaboration.
• Support regulatory submissions, inspection readiness, and audits.

Qualifications

• B.S. in chemistry, biology, biochemistry, or related field 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent.
• Experience in method transfer/implementation; understanding of method lifecycle management.
• Strong technical writing, data analysis, problem-solving, and organizational skills.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint.

Contract Details

Contract position with possible extension.

Location

Location: Norton, MA, with occasional responsibilities at other locations.

Schedule

Weekend coverage is required. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.